Comirnaty for 6 months to 4 years old (bivalent, Original/Omicron BA.4-5)

(Note 2)Partial Change Approval

Coronavirus (SARS-CoV-2) RNA Vaccine (active ingredients: tozinameran and famtozinameran)

Approval Information

Brand NameComirnaty for 6 months to 4 years old (bivalent, Original/Omicron BA.4-5)

Generic NameCoronavirus (SARS-CoV-2) RNA Vaccine (active ingredients: tozinameran and famtozinameran)

ApprovedAugust 2023

Type(Note 2)Partial Change Approval

Review Reports

English Review Report

PDF · 503.88 KB

Japanese Review Report (1)

PDF · 579.63 KB

Japanese Review Report (2)

PDF · 111.72 KB

Want structured data, translation summaries & alerts?

PharmaLens is building the most comprehensive English-language PMDA intelligence platform. Join the waitlist for early access.

Join the Waitlist

Source: PMDA Website. Review reports are provided under Japan's Public Data License v1.0. Translations and structured data by PharmaLens are unofficial and for reference only.

← Back to Drug Database